RAF Current Clinical Trials
Below you will find information about current ongoing Clinical Trials at Retina Associates. Just click on any of the buttons below to open the specific research information.
DRY AMD – Geographic Atrophy
DERBY OAKS
Apellis Pharmaceuticals
COMPARES: APL-2 inj Q1 or Q2 mos to sham inj Q1 or Q2 mos
ELIGIBILITY: patients with areas of geographic atrophy, VA 20/320 or better
DURATION: pt is enrolled for 2 years
QUESTION: Will APL-2 prevent progression of GA
WET AMD
AQUARIUS
ADVM-022-13A Multi-Center, Randomized, Double-Masked, Active-Comparator-Controlled,
Phase 3 Study to Evaluate the Efficacy and Safety of ixoberogene soroparvovec
(Ixo-vec) in Participants with Neovascular Age-Related Macular Degeneration
(AQUARIUS)COMPARES: The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to intravitreal aflibercept (active comparator).
ELIGIBILITY: Participants With Neovascular Age-related Macular Degeneration
DURATION: 52, 56 Weeks
QUESTION: Ixo-vec (also known as ADVM-022 or AAV.7m8-aflibercept) is an adeno-associated virus (AAV)-based gene therapy product being developed for the treatment of nAMD. Can Ixo-vec reduce the current treatment burden in patients with neovascular age related macular degeneration?ARCHWAY/PORTAL
Genentech/Roche Pharmaceuticals
COMPARES: Ranibizumab Port Delivery System (RPDS) Q 6mo refill vs Lucentis Q1 mo injections
ELIGIBILITY: VA 20/400 or better. Diagnosed with WET AMD, less than 6 months treatment
DURATION: pt is enrolled for 2 years
QUESTION: is RPDS with q6 month refills more effective than Lucentis monthlyGovernment Clinical Trials page
DRCR Protocol AO
DRCR Network
COMPARES: Home OCT-guided treatment (Notal Home OCT) versus treat-and-extend treatment with Faricimab (Vabysmo) for the management of wet AMD
ELIGIBILITY: new diagnosis of CNV, Vision better than 20/320
DURATION: 2 years
QUESTION: Does Home OCT-guided treatment result in better visual acuity and fewer number of injections than treat-and-extend treatmentBURGUNDY
Genentech/Roche Pharmaceuticals
COMPARES: Port Delivery System (PDS) with Zifimacinmig 40 mg vs 80 mg vs Ranibizumab 100 mg
ELIGIBILITY: diagnosis of CNV involving macula within 9 months, treatment with at least 2 anti-VEGF within 6 months, Vision better than 20/200
DURATION: 2 years
QUESTION: Safety and durability of Zifimacinmig compared to Ranibizumab
DIABETIC MACULAR EDEMA
ECLIPSE EC-104-CS-201
Eclipse Life Sciences
COMPARES: EC-104 high-dose implant vs EC-104 low-dose implant vs Ozurdex implant in patients with DME
ELIGIBILITY: prior suboptimal response with anti-VEGF within 24 months, Vision better than 20/400, foveal-center-involving DME with OCT CFT > 400 microns, HbA1c <10.0
DURATION: 9 months
QUESTION: Safety and durability of EC-104 high-dose and low-dose implant vs Ozurdex implantPAGODA
COMPARES: Ranibizumab Port Delivery System (RPDS) Q 6mo refill vs Lucentis Q1 mo injections
ELIGIBILITY: Type 1 or 2, VA: 20/40-20/400, no DME treatment in the last 3 months
DURATION: pt is enrolled for 2 years QUESTION: is RPDS with q6 month refills non-inferior to Lucentis monthly injections?
CHOROIDAL MELANOMA
AURA BIOSCIENCES
Aura Biosciences
COMPARES: Efficacy and safety of Suprachoroidal injection of Belzupacap Sarotalocan (Bel-Sar, AU-011) with laser activation compared to sham control in small choroidal melanoma
ELIGIBILITY: Small primary uveal melanoma (excluding iris melanoma) with documented growth
DURATION: 1 year
QUESTION: Does treatment with Bel-Sar result in lower time to tumor progression than sham control in small choroidal melanomaDRCR Protocol AL
DRCR Network
COMPARES: Effect of intravitreal Faricimab (Vabysmo) or Fluocinolone implant (Iluvien) compared with observation on long-term visual acuity and radiation retinopathy following treatment of choroidal melanoma with iodine-125 plaque brachytherapy
ELIGIBILITY: Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy
DURATION: 3 years
QUESTION: Does treatment with Vabysmo or Iluvien result in better vision and radiation retinopathy outcomes than primary observation in choroidal melanoma treated with plaque brachytherapy
RETINAL VEIN OCCLUSION – STUDIES CLOSED
BALATON
COMPARES: Faricimab Q4-16-week injections vs Aflibercept Q4 week injections
ELIGIBILITY: Branch Retinal Vein Occlusion with Macular Edema (treatment naïve).
DURATION: pt is enrolled for 2 years
QUESTION: Will Faricimab Q4-16-week injection group be noninferior to the Aflibercept q4-week groupCOMINO
COMPARES: Faricimab Q4-16-week injections vs Aflibercept Q4 week injections
ELIGIBILITY: Central Retinal Vein Occlusion with Macular Edema (treatment naïve).
DURATION: pt is enrolled for 2 years
QUESTION: Will Faricimab Q4-16-week injection group be noninferior to the Aflibercept q4-week group
We encourage you to refer potential patients for free screening as they would benefit from participation in these studies. The trials are sponsored, so eligible patients will NOT incur additional costs and transportation is provided if needed.
If you have a patient with one of these conditions, please call us to make their referral appointment and mention the clinical trial when making the appointment. Please complete our Clinical Trial Referral Form and ask your patient to bring with them to their appointment.
If you are working on a weekend or after 5:00pm, please complete the Clinical Trial Referral Form and fill it out, then FAX it to our office. We will then contact the patient to make the appointment.
For the initial evaluation, the patient will need to provide their own transportation. If they qualify for the trial, then future transportation will be provided by RAF (via Uber or Taxi).
Questions:
Heidi Appenzeller
Study Coordinator
retinahv@tampabay.rr.com
Ferdinand Rosado
retinafr@gmail.com
Alyssa Loser
almretina@gmail.com
813-875-6373 ext 239